Safety device for a medicament container

ABSTRACT

A safety device for a medicament container includes a first sheath having a first ledge and a second ledge, a second sheath telescopically arranged with the first sheath and releasably coupled to the first ledge, and a finger flange having at least one resilient clip adapted to engage the second ledge first sheath.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/914,759, filed Feb. 26, 2016, which is a U.S. national stageapplication under 35 USC § 371 of International Application No.PCT/EP2014/068130, filed on Aug. 27, 2014, which claims priority toEuropean Patent Application No. 13306179.6, filed on Aug. 29, 2013, theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to a safety device for a medicament container.

BACKGROUND

Administering an injection is a process which presents a number of risksand challenges for users and healthcare professionals, both mental andphysical. Medicament delivery devices typically fall into twocategories—manual devices and auto-injectors. In a conventional manualdevice, manual force is required to drive a medicament through a needle.This is typically done by some form of button/plunger that has to becontinuously pressed during the injection. A conventional auto-injectormay provide the force for administering the medicament by a spring, anda trigger button or other mechanism may be used to activate theinjection.

For use of manual devices and autoinjectors, safety and usability are ofthe utmost importance. Thus, there remains a need for improvedmedicament delivery devices which include components or mechanisms foruser and patient safety (e.g., to prevent misuse, needlestick, etc.) andenhanced usability (e.g., making the device easier to user before,during and after an injection to improve dose accuracy and compliance).

SUMMARY

Certain embodiments of the present invention provide improved safetydevices for a medicament containers.

In an exemplary embodiment according to the present invention, a safetydevice for a medicament container comprises a first sheath having afirst ledge and a second ledge, a second sheath telescopically arrangedwith the first sheath and releasably coupled to the first ledge, and afinger flange having at least one resilient clip adapted to engage thesecond ledge first sheath.

In an exemplary embodiment the resilient clip comprises a transversebeam extending in a radial inward direction, a longitudinal beamextending from the transverse beam in a proximal direction, a hookcomprising a slope surface and a block surface extending from thelongitudinal beam in the radial inward direction, wherein duringinsertion of the outer ledge in a distal direction the second ledgeengages the slope surface increasingly deflecting the resilient clip ina radial outward direction, wherein, after the second ledge has passedthe slope surface the resilient clip relaxes and the second ledge (36)engages the block surface preventing the second ledge from returning inthe proximal direction.

In an exemplary embodiment of the transverse beam comprises a hinge inthe shape of a section with a reduced thickness compared to the rest ofthe transverse beam.

In an exemplary embodiment the hinge has a thickness of approximately30% to 70%, in particular 40% to 60% of the thickness of the rest of thetransverse beam.

In an exemplary embodiment a protrusion is arranged on one of the fingerflange and the first sheath, the protrusion arranged to engage a recessin the other one of the finger flange and the first sheath so as tolimit relative rotation between the first sheath and the finger flange.

In an exemplary embodiment, the finger flange comprises a hole adaptedto receive the first sheath. The finger flange comprises a centralrecess disposed adjacent to the hole adapted to receive the secondledge.

In an exemplary embodiment, the finger flange comprises a retaining walladapted to abut the second ledge. The retaining wall abuts an entireperiphery of the second ledge.

In an exemplary embodiment, the finger flange comprises at least onelateral recess disposed adjacent the hole.

In an exemplary embodiment, the finger flange comprises a centralportion and at least one support portion extending radially from thecentral portion. The at least one support portion includes a supportsurface and wherein the support surface is made from a first materialand the support portion is made from a second material, and wherein thefirst material has a lower durometer than the second material. Thesupport surface may include one or more frictional features.

In an exemplary embodiment the support surface is formed by overmoldingor by two-shot injection molding.

In an exemplary embodiment, a radial distance between an outer radialsurface and an outer diameter of the hole is approximately 20 mm.

In an exemplary embodiment, the central portion comprises asubstantially flat proximal surface and a concave distal surface, andthe at least one support portion comprises a substantially flat proximalsurface and a concave distal surface.

In an exemplary embodiment, the central portion comprises asubstantially flat proximal surface and a substantially flat distalsurface, and the at least one support portion comprises a concaveproximal surface and a concave distal surface.

In an exemplary embodiment according to the present invention, amedicament delivery device comprises a medicament container and a safetydevice according to any one of the exemplary embodiments.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of the present invention will become more fullyunderstood from the detailed description given herein below and theaccompanying drawings which are given by way of illustration only, andthus, are not limitive of the present invention, and wherein:

FIG. 1 shows a medicament delivery device according to certainembodiments of the present invention,

FIG. 2 shows a medicament container according to the present invention,

FIG. 3 shows a safety device according to the present invention,

FIGS. 4A and 4B show a plunger according to the present invention,

FIGS. 5A and 5B show a cap according to certain embodiments of thepresent invention,

FIG. 6 shows a cap according to certain embodiments of the presentinvention,

FIG. 7 shows a finger flange according to certain embodiments of thepresent invention,

FIG. 8 shows another finger flange according to certain embodiments ofthe present invention, and

FIG. 9 shows a finger flange according to certain embodiments of thepresent invention, and

FIG. 10 shows a finger flange according to certain embodiments of thepresent invention,

FIG. 11 shows a sectional detail view of a finger flange according tocertain embodiments of the present invention, and

FIG. 12 shows a sectional detail view of a finger flange according tocertain embodiments of the present invention.

Corresponding parts are marked with the same reference symbols in allfigures.

DETAILED DESCRIPTION

FIG. 1 shows a medicament delivery device 10 according to certainembodiments of the present invention. In an exemplary embodiment, thedelivery device 10 comprises a medicament container 20, a safety device30 and a plunger 40. The delivery device 10 may further include a fingerflange 50 and/or a cap 60.

FIG. 2 shows an exemplary of a medicament container 20 according to thepresent invention. In the exemplary embodiment, the medicament container20 includes a barrel 22, a stopper 24 slidably disposed in the barrel 22and a needle 26 coupled to a distal end of the barrel 22. In anexemplary embodiment, the stopper 24 may be made from a rubber material.A proximal end of the barrel 22 includes a flange 28 which may be fullyor partial circular, elliptical, square, rectangular or any other shape.The barrel 22 may be any size (e.g., 0.5 ml, 1 ml, 2 ml, etc.) and bemade of any suitable material (e.g., plastic, glass). In an exemplaryembodiment, the barrel 22 may be manufactured from Type I clear glass.In an exemplary embodiment, the stopper 24 is made from a rubbermaterial. In an exemplary embodiment, the needle 26 is made fromstainless steel. The needle 26 may be any gauge or length.

In an exemplary embodiment, a needle shield 29 may be removably coupledto the distal end of the barrel 22 to cover the needle 26. In anexemplary embodiment, the needle shield 29 may be a sheath 29.1 made of,for example, rubber or elastomer latex.

In another exemplary embodiment, the needle shield 29 may furtherinclude a casing 29.2 made of, for example, polypropylene or any othersimilar material. The casing 29.2 may be disposed partially or entirelyon an outer surface of the sheath 29.1. The casing 29.2 may providefurther support to the sheath 29.1 to, for example, prevent the needle26 from bending or puncturing the sheath 29.1. When the needle shield 29is removed, the needle 26 is exposed.

FIG. 3 shows a safety device 30 according to certain embodiments of thepresent invention. In the exemplary embodiment, the safety device 30comprises a first sheath 31 arranged telescopically with a second sheath32, and the sheaths 31, 32 which are biased relative to each other by aspring 33. Prior to use, one of the sheaths is in a retracted positionrelative to the other sheath, and after use, the one of the sheaths isin an extended position relative to the other sheath to cover the needle26. In the extended position, the one of the sheaths is locked in theextended position to prevent retraction and uncovering of the needle 26.

In the exemplary embodiment shown in FIG. 3, the first sheath 31 is anouter sheath, and the second sheath 32 is an inner sheath, and thesecond sheath 32 is movable from the retracted position to the extendedposition relative to the first sheath 31. The first sheath 31 comprisesan open distal end allowing the second sheath 32 to move from theretracted position to the distal position. A proximal end of the firstsheath 31 includes an engagement arrangement 34 adapted to engage theflange 28 of the medicament container 20. In an exemplary embodiment,the engagement arrangement 34 includes a support surface 34.1 adapted toabut a distal surface of the flange 28 to prevent distal movement of themedicament container 20 relative to the first sheath 31, and one or moreresilient hooks 34.2 adapted to engage the flange 28 to prevent proximalmovement of the medicament container 20 relative to the first sheath 31.When the medicament container 20 is inserted into the first sheath 31,the flange 28 causes the resilient hooks 34.2 to deflect until theflange 28 is distal of the hooks 34.2, at which point the hooks 34.2return to a non-deflected position and can abut a proximal surface ofthe flange 28.

In an exemplary embodiment, the proximal end of the first sheath 31includes an inner ledge 35 and an outer ledge 36. The inner ledge 35 maybe formed partially or entirely around a proximal opening of the firstsheath 31. The outer ledge 36 may be formed partially or entirely aroundan outer surface of the first sheath 31. As shown in the exemplaryembodiment in FIG. 3, the first sheath 31 may have a distal portionhaving a first outer diameter and a proximal portion having a secondouter diameter which is larger than the first outer diameter. The outerledge 36 may be formed partially or entirely around the larger secondouter diameter to provide a support surface for a user's fingers.

In an exemplary embodiment, the second sheath 32 comprises an opendistal end allowing the needle 26 to pass through when the second sheath32 is in the retracted position. A proximal end of the second sheath 32includes one or more resilient arms 37 adapted to releaseably engage theinner ledge 35 to maintain the second sheath 32 in the retractedposition against the force of the spring 33 which biases the secondsheath 32 towards the extended position. When the second sheath 32 is inthe retracted position, the resilient arms 37 are radially biased toengage the inner ledge 35.

In an exemplary embodiment, the first sheath 31 is made frompolycarbonate, the second sheath is made from copolyesther, and thespring 33 is made from stainless steel.

FIGS. 4A and 4B show a plunger 40 according to certain embodiments ofthe present invention. In the exemplary embodiment, the plunger 40includes a distal end 41 adapted to engage the stopper 24, a proximalend 42 adapted to be pressed by a user, and a stem 43 connecting thedistal and proximal ends 41, 42. FIG. 4B shows a partial cross-sectionof an exemplary embodiment of the proximal end 42 of the plunger 40. Inthe exemplary embodiment, the proximal end 42 includes a bearing surface42.1 adapted to receive a user's finger. The bearing surface 42.1 may beflat (perpendicular relative to a longitudinal axis of the medicamentcontainer 20) or have a partially or entirely concave or convex surface.In another exemplary embodiment, the bearing surface 42.1 may have oneor more surface elements (e.g., ridges, bumps, etc.) adapted tofrictionally engage the user's finger to prevent it from slipping offthe bearing surface 42.1 during use. The proximal end 42 furtherincludes a radial surface 42.2 having a distal end that is adapted toengage one or more resilient projections on the first sheath 31 thatdeflect upon engagement with the radial surface 42.2 to engage the oneor more resilient arms 37 on the second sheath 32 when the plunger 40has been pressed a sufficient distance relative to the medicamentcontainer 20. In an exemplary embodiment, the distal end of the radialsurface 42.2 may comprise one or more ramps 42.3 adapted to engage theresilient projections such that the resilient rejections resilient arms37 deflect and disengage the inner ledge 35.

In an exemplary use, when the plunger 40 is pressed a sufficientdistance, the ramps 42.3 engage the resilient projections which engagethe resilient arms 37 such that the resilient arms 37 deflect anddisengage the inner ledge 35. The force of the spring 33 pushes thesecond sheath 32 distally relative to the first sheath 31 from theretracted position to the extended position. The second sheath 32 islocked in the extended position, because the resilient arms 37 abut astop surface 31.1 (shown in FIG. 3) on the first sheath 31 preventingthe second sheath 32 from moving proximally relative to the first sheath31 from the extended position.

In an exemplary embodiment, the plunger 40 is made from polypropylene.

In an exemplary embodiment, the safety device 30 and the plunger 40 maybe as described in U.S. Patent Application Publication No. 2002/0193746,the entire disclosure of which is expressly incorporated herein byreference.

FIGS. 5A and 5B show a cap 60 according to certain embodiments of thepresent invention. In the exemplary embodiment, the cap 60 comprisescylindrical portion 61 having a first outer diameter and a disc portion62 having a second outer diameter larger than the second outer diameter.The cylindrical portion 61 includes a thru hole 61.1 adapted toaccommodate the needle shield 29. The disc portion 62 may include a thruhole coaxial with the thru hole 61.1 or may include a full or partialcover to fully or partially enclose the thru hole 61.1. When assembled aproximal end of the cylindrical portion 61 may abut a distal end of thefirst sheath 31.

In an exemplary embodiment, the cap 60 may be made from polypropylene.

In an exemplary embodiment, a gripping surface 63 may be coupled to thecap 60. In the exemplary embodiment, the gripping surface 63 includes aproximal portion 63.1 and a distal portion 63.2. The proximal portion63.1 may be coupled to all or part of an outer surface of thecylindrical portion 61 of the cap 60 and/or all or part of a proximalsurface of the disc portion 62. The distal portion 63.2 may be coupledto all of part of an inner surface of the cylindrical portion 61 of thecap 60 and/or all or part of a distal surface of the disc portion 62. Inanother exemplary embodiment, the proximal portion 63.1 or the distalportion 63.2 may be disposed partially or entirely around acircumference of the disc portion 62.

In an exemplary embodiment, the gripping surface 63 may be made from amaterial having a lower durometer than the material comprising the cap60. In an exemplary embodiment, the gripping surface 63 may be elastomerthermoplastic. The gripping surface 63 may provide an easily grippableand supportive surface for a user to grip to remove the cap 60 from themedicament delivery device 10. In an exemplary embodiment, any part ofthe gripping surface 63 may include one or more frictional features(e.g., ridges, bumps, etc.) to ensure that the user's fingers do notslip when gripping and removing the cap 60.

FIG. 6 shows an exemplary embodiment of a cap 60 coupled to themedicament delivery device 10. In the exemplary embodiment, the distalportion 63.2 of the gripping surface 63 is partially disposed on theinner surface of the cylindrical portion 61 of the cap 60. In anexemplary embodiment, a thickness of the distal portion 63.2 maydecrease along the length of the inner surface in the proximaldirection. A proximal end of the distal portion 63.2 along the length ofthe inner surface may include a ramp feature 63.2.1 adapted to receiveand guide the needle shield 29, e.g., during assembly. The distalportion 63.2 of the gripping surface 63 is adapted to frictionallyengage the needle shield 29, such that when the cap 60 is pulled awayfrom the medicament delivery device 10, the needle shield 29 is removed.In another exemplary embodiment, all or part of the distal portion 63.2may include one or more engagement features (e.g., a barb, a hook, aprojection, etc.) adapted to engage the needle shield 29 (or any featurethereof, e.g., a slot, a channel, a recess, etc.) when the needle shield29 is inserted into the cap 60. In an exemplary embodiment, the distalportion 63.2 may include one or more separate pieces of material. Forexample, a first piece of material may be disposed on the inner surfaceof the cylindrical portion 61 and a second piece of material may bedisposed on the distal surface of the disc portion 62. A thru-hole 62.1may be formed in the disc portion 62, e.g., for molding the grippingsurface 63.

In an exemplary embodiment, the cap 60 and/or the gripping surface 63may include one or more indicia for indicating how to remove the cap 60.For example, all or part of the cap 60 may be a first color and all orpart of the gripping surface 63 may be a second color different from thefirst color to signify that this is the needle end of the device 10. Inanother exemplary embodiment, one or more words or symbols may bedisposed on the cap 60 and/or the gripping surface 63. For example, anarrow point in the distal direction and/or the words “PULL” or “DO NOTTWIST” may be disposed on the cap 60 and/or the gripping surface 63.

FIG. 7 shows a finger flange 50 according to certain embodiments of thepresent invention. FIG. 8 shows another finger flange 500 according tocertain embodiments of the present invention. FIG. 9 shows a proximalview of a finger flange 50/500 according to certain embodiments of thepresent invention.

As shown in the exemplary embodiment in FIG. 9, a proximal surface ofthe finger flange 50/500 include a hole 70 adapted to receive the firstsheath 31. In an exemplary embodiment, a diameter of the hole 70 isapproximately equal to an outer diameter of the first sheath 31. Acentral recess 71 may be formed around the hole 70 and be adapted toaccommodate a proximal portion of the first sheath 31. For example, thecentral recess 71 may include a bearing surface 71.1 adapted to abut adistal face of the outer ledge 36. The central recess 71 may furtherinclude a retaining wall 71.2 adapted to abut at least a portion of theouter ledge 36 to prevent rotation of the first sheath 31 relative tothe finger flange 50/500. One or more resilient clips 72 are disposedwithin or adjacent the central recess 71 and adapted to engage the outerledge 36. When the finger flange 50/500 is coupled to the first sheath31, the clips 72 deflect to accommodate the outer ledge 36 and thenreturn to a non-deflected position to engage the outer ledge 36.

In another exemplary embodiment, the bearing surface 71.1 may not berecessed but may be in plane with the proximal surface of the fingerflange 50/500. In this exemplary embodiment, the retaining wall 71.2 andthe clips 72 may extend proximally from the flat surface.

In an exemplary embodiment, the proximal surface of the finger flange50/500 may include one or more lateral recesses 73 adjacent the centralrecess 71. The lateral recesses 73 may be formed to create a hingeeffect when supporting the user's fingers. The lateral recesses 73 mayfurther decrease weight of the finger flange 50/500 and reduceconstraints on molding.

FIG. 7 shows an exemplary embodiment of the finger flange 50 disposed onthe outer sheath 31. In the exemplary embodiment, the finger flange 50includes one or more support portions 51 extending radially from acentral portion 52. The proximal surface of the finger flange 50 issubstantially flat and distal surfaces of the support portions 51 andthe central portion 52 are concave relative to the proximal surface(e.g., when the finger flange 50 is placed on a flat surface such thatthe proximal surface engages the flat surface). The support portion 51may include a support surface 53. In an exemplary embodiment, thesupport surface 53 may be made, e.g. by overmolding or by two-shotinjection molding, from a material having a lower durometer than thematerial comprising the finger flange 50. In an exemplary embodiment,the support surface 53 may be elastomer thermoplastic. The grippingsurface 53 may provide a surface for a user's finger when administeringan injection. In an exemplary embodiment, any part of the supportsurface 53 may include one or more frictional features (e.g., ridges,bumps, etc.) to ensure that the user's fingers do not slip whenadministering the injection. Likewise, the support surface 53 may beformed without such surface structures. While the exemplary embodimentof the invention shows two support portions 51 extending radially in awing-like fashion from the central portion 52, those of skill in the artwill understand that any number of support portions 51 in any shape,size or dimension may be utilized based on the intended application. Forexample, a radial distance R between an outer radial surface 54 and aninner radial surface 55 may be approximately 20 mm. However, for usewith elderly or arthritic patients, the radial distance may beincreased, and the support portions may be larger.

In an exemplary embodiment, the finger flange 50 may be made frompolypropylene or acrylonitrile butadiene styrene and the supportsurfaces 53 may be made from elastomer thermoplastic.

FIG. 8 shows an exemplary embodiment of the finger flange 500 disposedon the outer sheath 31. In the exemplary embodiment, the finger flange500 includes one or more support portions 501 extending radially from acentral portion 502. Proximal and distal surfaces of the supportportions 501 are concave, and proximal and distal surfaces of thecentral portion 502 are substantially flat (e.g., approximatelyperpendicular to a longitudinal axis of the first sheath 31). Thesupport portion 501 may include a support surface 503. In an exemplaryembodiment, the support surface 503 may be made, e.g. by overmolding orby two-shot injection molding, from a material having a lower durometerthan the material comprising the finger flange 500. In an exemplaryembodiment, the support surface 503 may be elastomer thermoplastic. Thegripping surface 503 may provide a surface for a user's finger whenadministering an injection. In an exemplary embodiment, any part of thesupport surface 503 may include one or more frictional features (e.g.,ridges, bumps, etc.) to ensure that the user's fingers do not slip whenadministering the injection. Likewise, the support surface 53 may beformed without such surface structures. While the exemplary embodimentof the invention shows two support portions 501 extending radially in awing-like fashion from the central portion 502, those of skill in theart will understand that any number of support portions 501 in anyshape, size or dimension may be utilized based on the intendedapplication. For example, a radial distance R between an outer radialsurface 504 and an inner radial surface 505 may be approximately 20 mm.However, for use with elderly or arthritic patients, the radial distancemay be increased, and the support portions may be larger.

In an exemplary embodiment, the finger flange 500 may be made frompolypropylene or acrylonitrile butadiene styrene and the supportsurfaces 503 may be made from elastomer thermoplastic.

FIG. 10 shows a finger flange 50 according to certain embodiments of thepresent invention. A proximal surface of the finger flange 50 includes ahole 70 adapted to receive the first sheath 31. In an exemplaryembodiment, a diameter of the hole 70 is approximately equal to an outerdiameter of the first sheath 31. A central recess 71 may be formedaround the hole 70 and be adapted to accommodate a proximal portion ofthe first sheath 31. For example, the central recess 71 may include abearing surface 71.1 adapted to abut a distal face of the outer ledge36. The central recess 71 may further include a retaining wall 71.2adapted to abut at least a portion of the outer ledge 36 to preventrotation of the first sheath 31 relative to the finger flange 50. One ormore resilient clips 72 are disposed within or adjacent the centralrecess 71 and adapted to engage the outer ledge 36. When the fingerflange 50 is coupled to the first sheath 31, the clips 72 deflect toaccommodate the outer ledge 36 and then return to a non-deflectedposition to engage the outer ledge 36.

In another exemplary embodiment, the bearing surface 71.1 may not berecessed but may be in plane with the proximal surface of the fingerflange 50. In this exemplary embodiment, the retaining wall 71.2 and theclips 72 may extend proximally from the flat surface.

In an exemplary embodiment, the proximal surface of the finger flange 50may include one or more lateral recesses 73 adjacent the central recess71. The lateral recesses 73 may be formed to create a hinge effect whensupporting the user's fingers. The lateral recesses 73 may furtherdecrease weight of the finger flange 50 and reduce constraints onmolding.

In an exemplary embodiment a protrusion 71.3 is arranged in theretaining wall 71.2 in a manner to engage a respective recess (notillustrated) in the outer ledge 36 so as to avoid and/or limit relativerotation between the first sheath 31 and the finger flange 50.

In another exemplary embodiment the protrusion 71.3 could be arranged inthe hole 70 in a manner to engage a respective recess (not illustrated)in the first sheath 31. In the illustrated embodiment the protrusion71.3 has an arcuate shape. Those skilled in the art will understand thatthe protrusion 71.3 may take any other form. Likewise, it would bepossible to arrange the protrusion 71.3 on the first sheath 31 or on theouter ledge 36 in a manner to let it engage a corresponding recess inthe retaining wall 71.2 or in the hole 70.

FIG. 11 shows a sectional detail view of an exemplary embodiment of afinger flange 50 according to certain embodiments of the presentinvention. The resilient clip 72 comprises a transverse beam 72.1originating from the finger flange 50 and extending in a radial inwarddirection I. The transverse beam 72.1 may be arranged substantially inparallel with the finger flange 50, i.e. substantially at right angleswith respect to the first sheath 31 to be received within the hole 70.The resilient clip 72 furthermore comprises a longitudinal beam 72.2originating from a radial inward end of the transverse beam 72.1 andextending in a proximal direction P. A hook comprising a slope surface72.3 and a block surface 72.4 is arranged on the proximal end of thelongitudinal beam 72.2 and extends in the radial inward direction I. Theslope surface 72.3 allows for inserting the outer ledge 36 of the firstsheath 31 in a distal direction D, wherein the outer ledge 36 engagesthe slope surface 72.3 increasingly deflecting it in a radial outwarddirection O due to the resilient properties of the transverse beam 72.1and/or the longitudinal beam 72.2. Once the outer ledge 36 has passedthe slope surface 72.3 during insertion the resilient clip 72 relaxesand returns in the radial inward direction I. The distally facing blocksurface 72.4 thus engages a proximal face of the outer ledge 36preventing it from returning in the proximal direction P.

FIG. 12 shows a sectional detail view of an exemplary embodiment of afinger flange 50 according to certain embodiments of the presentinvention. The embodiment substantially corresponds to the embodiment ofFIG. 11. However, the embodiment of FIG. 12 differs from the embodimentof FIG. 11 in that the transverse beam 72.1 comprises a hinge 72.1.1,i.e. a section in which a thickness of the transverse beam 72.1 isreduced with respect to the rest of the transverse beam 72.1. In anexemplary embodiment the hinge 72.1.1 has a thickness of approximately30% to 70%, in particular 40% to 60% of the thickness of the rest of thetransverse beam 72.1. In an exemplary embodiment the hinge 72.1.1 isarranged adjacent the longitudinal beam 72.2.

While exemplary embodiments of the components and/or portions of the cap60 are described as having certain shapes (e.g., cylinders, discs, etc.)with certain properties that connote a shape (e.g., a diameter,circumference, etc.), those of skill in the art will understand that thecap 60 according to present invention is not limited to any shape orsize, but may be adapted for any application or use.

While exemplary embodiments of the present invention are described asbeing made from certain materials, those of skill in the art willunderstand that other materials (and/or combinations of materials) maybe utilized based on the intended application or use.

The term “drug” or “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or afragment thereof, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound, wherein in a furtherembodiment the pharmaceutically active compound is useful for thetreatment and/or prophylaxis of diabetes mellitus or complicationsassociated with diabetes mellitus such as diabetic retinopathy,thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis, wherein in a furtherembodiment the pharmaceutically active compound comprises at least onepeptide for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, wherein in a further embodiment the pharmaceutically activecompound comprises at least one human insulin or a human insulinanalogue or derivative, glucagon-like peptide (GLP-1) or an analogue orderivative thereof, or exendin-3 or exendin-4 or an analogue orderivative of exendin-3 or exendin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

des Pro36 Exendin-4(1-39),

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of theExendin-4 derivative;

or an Exendin-4 derivative of the sequence

des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,

des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(S1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any one of theafore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (˜150 kDa) that are also knownas immunoglobulins which share a basic structure. As they have sugarchains added to amino acid residues, they are glycoproteins. The basicfunctional unit of each antibody is an immunoglobulin (Ig) monomer(containing only one Ig unit); secreted antibodies can also be dimericwith two Ig units as with IgA, tetrameric with four Ig units liketeleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a “Y”-shaped molecule that consists of fourpolypeptide chains; two identical heavy chains and two identical lightchains connected by disulfide bonds between cysteine residues. Eachheavy chain is about 440 amino acids long; each light chain is about 220amino acids long. Heavy and light chains each contain intrachaindisulfide bonds which stabilize their folding. Each chain is composed ofstructural domains called Ig domains. These domains contain about 70-110amino acids and are classified into different categories (for example,variable or V, and constant or C) according to their size and function.They have a characteristic immunoglobulin fold in which two β sheetscreate a “sandwich” shape, held together by interactions betweenconserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ,and μ. The type of heavy chain present defines the isotype of antibody;these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies,respectively.

Distinct heavy chains differ in size and composition; α and γ ωntainapproximately 450 amino acids and δ approximately 500 amino acids, whilep and E have approximately 550 amino acids. Each heavy chain has tworegions, the constant region (C_(H)) and the variable region (V_(H)). Inone species, the constant region is essentially identical in allantibodies of the same isotype, but differs in antibodies of differentisotypes. Heavy chains γ, α and δ have a constant region composed ofthree tandem Ig domains, and a hinge region for added flexibility; heavychains μ and ε have a constant region composed of four immunoglobulindomains. The variable region of the heavy chain differs in antibodiesproduced by different B cells, but is the same for all antibodiesproduced by a single B cell or B cell clone. The variable region of eachheavy chain is approximately 110 amino acids long and is composed of asingle Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted byλ and κ. A light chain has two successive domains: one constant domain(CL) and one variable domain (VL). The approximate length of a lightchain is 211 to 217 amino acids. Each antibody contains two light chainsthat are always identical; only one type of light chain, κ or λ, ispresent per antibody in mammals.

Although the general structure of all antibodies is very similar, theunique property of a given antibody is determined by the variable (V)regions, as detailed above. More specifically, variable loops, threeeach the light (VL) and three on the heavy (VH) chain, are responsiblefor binding to the antigen, i.e. for its antigen specificity. Theseloops are referred to as the Complementarity Determining Regions (CDRs).Because CDRs from both VH and VL domains contribute to theantigen-binding site, it is the combination of the heavy and the lightchains, and not either alone, that determines the final antigenspecificity.

An “antibody fragment” contains at least one antigen binding fragment asdefined above, and exhibits essentially the same function andspecificity as the complete antibody of which the fragment is derivedfrom. Limited proteolytic digestion with papain cleaves the Ig prototypeinto three fragments. Two identical amino terminal fragments, eachcontaining one entire L chain and about half an H chain, are the antigenbinding fragments (Fab). The third fragment, similar in size butcontaining the carboxyl terminal half of both heavy chains with theirinterchain disulfide bond, is the crystalizable fragment (Fc). The Fccontains carbohydrates, complement-binding, and FcR-binding sites.Limited pepsin digestion yields a single F(ab′)2 fragment containingboth Fab pieces and the hinge region, including the H—H interchaindisulfide bond. F(ab′)2 is divalent for antigen binding. The disulfidebond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, thevariable regions of the heavy and light chains can be fused together toform a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the apparatuses, methodsand/or systems and embodiments described herein may be made withoutdeparting from the full scope and spirit of the present invention, whichencompass such modifications and any and all equivalents thereof.

REFERENCES

-   10 medicament delivery device-   20 medicament container-   22 barrel-   24 stopper-   26 needle-   28 flange-   29 needle shield-   29.1 sheath-   29.2 casing-   30 safety device-   31 first sheath-   31.1 stop surface-   32 second sheath-   33 spring-   34 engagement arrangement-   34.1 support surface-   34.2 resilient hook-   35 inner ledge-   36 outer ledge-   37 resilient arm-   40 plunger-   41 distal end-   42 proximal end-   42.1 bearing surface-   42.2 radial surface-   42.3 ramp-   43 stem-   50 finger flange-   51 support portion-   52 central portion-   53 support surface-   54 outer radial surface-   55 inner radial surface-   60 cap-   61 cylindrical portion-   61.1 thru hole-   62 disc portion-   62.1 thru hole-   63 gripping surface-   63.1 proximal portion-   63.2 distal portion-   63.2.1 ramp feature-   70 hole-   71 central recess-   71.1 bearing surface-   71.2 retaining wall-   71.3 protrusion-   72 resilient clip-   72.1 transverse beam-   72.1.1 hinge-   72.2 longitudinal beam-   72.3 slope surface-   72.4 block surface-   73 lateral recess-   500 finger flange-   501 support portion-   502 central portion-   503 support surface-   504 outer radial surface-   505 inner radial surface-   D distal direction-   I radial inward direction-   O radial outward direction-   P proximal direction-   R radial distance

The invention claimed is:
 1. A safety device for a medicament container,the safety device comprising: a first sheath comprising a first ledgeand a second ledge; a second sheath telescopically arranged with thefirst sheath and releasably coupled to the first ledge; and a fingerflange comprising: a resilient clip adapted to engage the second ledgeof the first sheath, a central portion comprising a substantially flatproximal surface and a distal surface that is concave or substantiallyflat, and a support portion extending radially from the central portion;wherein the resilient clip comprises a transverse beam extending in aradial inward direction and a longitudinal beam extending from thetransverse beam in a proximal direction, and wherein the transverse beamcomprises a hinge in the shape of a section with a reduced thicknesscompared to a remaining portion of the transverse beam.
 2. The safetydevice of claim 1, wherein the resilient clip comprises: a hookcomprising a slope surface and a block surface extending from thelongitudinal beam in the radial inward direction, wherein duringinsertion of the second ledge in a distal direction, the second ledgeengages the slope surface and increasingly deflects the resilient clipin a radial outward direction, and wherein after the second ledge haspassed the slope surface, the resilient clip relaxes and the secondledge engages the block surface to prevent the second ledge fromreturning in the proximal direction.
 3. The safety device of claim 1,wherein the hinge has a thickness of approximately 30% to 70% of athickness of the remaining portion of the transverse beam.
 4. The safetydevice of claim 1, wherein a protrusion is arranged on one of the fingerflange and the first sheath, and wherein the protrusion is arranged toengage a recess in the other one of the finger flange and the firstsheath so as to limit relative rotation between the first sheath and thefinger flange.
 5. The safety device of claim 1, wherein the fingerflange comprises: a hole adapted to receive the first sheath; and acentral recess disposed adjacent to the hole adapted to receive thesecond ledge.
 6. The safety device of claim 1, wherein the finger flangecomprises a retaining wall adapted to abut the second ledge.
 7. Thesafety device of claim 6, wherein the retaining wall abuts an entireperiphery of the second ledge.
 8. The safety device of claim 1, whereinthe finger flange comprises: a hole adapted to receive the first sheath;and a lateral recess disposed adjacent the hole.
 9. The safety device ofclaim 1, wherein the support portion comprises a support surface,wherein the support surface is made of a first material, wherein thesupport portion is made of a second material, and wherein the firstmaterial has a lower durometer than the second material.
 10. The safetydevice of claim 9, wherein the support surface comprises one or morefrictional features.
 11. The safety device of claim 10, wherein thesupport surface is formed by overmolding or by two-shot injectionmolding.
 12. The safety device of claim 1, wherein the finger flangecomprises a hole adapted to receive the first sheath, and wherein aradial distance between an outer radial surface and an outer diameter ofthe hole is approximately 20 mm.
 13. The safety device of claim 1,wherein the support portion comprises a substantially flat proximalsurface and a concave distal surface or a concave proximal surface and aconcave distal surface.
 14. A medicament delivery device, comprising: amedicament container; and a safety device for the medicament container,the safety device comprising: a first sheath comprising a first ledgeand a second ledge, a second sheath telescopically arranged with thefirst sheath and releasably coupled to the first ledge, and a fingerflange comprising: a resilient clip adapted to engage the second ledgeof the first sheath, a central portion comprising a substantially flatproximal surface and a distal surface that is concave or substantiallyflat, and a support portion extending radially from the central portion,wherein the resilient clip comprises a transverse beam extending in aradial inward direction and a longitudinal beam extending from thetransverse beam in a proximal direction, and wherein the transverse beamcomprises a hinge in the shape of a section with a reduced thicknesscompared to a remaining portion of the transverse beam.
 15. A safetydevice for a medicament container, the safety device comprising: a firstsheath comprising a first ledge and a second ledge; a second sheathtelescopically arranged with the first sheath and releasably coupled tothe first ledge; a finger flange comprising a resilient clip adapted toengage the second ledge of the first sheath; and a cap comprising acylindrical portion having a first outer diameter and a disc portionhaving a second outer diameter larger than the first outer diameter,wherein the resilient clip comprises a transverse beam extending in aradial inward direction and a longitudinal beam extending from thetransverse beam in a proximal direction, and wherein the transverse beamcomprises a hinge in the shape of a section with a reduced thicknesscompared to a remaining portion of the transverse beam.
 16. The safetydevice of claim 15, wherein the cylindrical portion comprises a throughhole adapted to accommodate a needle shield.